Latest news with #MazenNoureddin
Business Wire
16-06-2025
- Health
- Business Wire
D&D Pharmatech Announces Positive Phase 2 Results for DD01 in MASH with Robust Reductions in Liver Fat Accompanied by Improvements in Liver and Metabolic Health
GYEONGGI-DO, South Korea & GAITHERSBURG, Md.--(BUSINESS WIRE)--D&D Pharmatech, Inc. (D&D) (KOSDAQ: 347850), a clinical-stage biotechnology company developing breakthrough treatments for liver and metabolic diseases, today announced positive results from DD01-DN-02 study, an ongoing 48-week Phase 2 trial designed to evaluate the efficacy and safety of DD01 (a once-weekly dual GLP1/glucagon receptor agonist) in 67 overweight/obese subjects with MASH. DD01 treatment was initiated with two weeks of dosing at 20 mg, followed by the 40mg once-weekly maintenance dose. Results of a planned 12-week assessment of safety and efficacy revealed DD01 was well tolerated, and the study's primary endpoint was met. Following a 1:1 randomization of 40mg DD01 and placebo, 75.8% of subjects treated with DD01 achieved at least a 30% reduction in liver fat, 72.7% of subjects achieved greater than 50% reduction in liver fat, and 57.6% of subjects achieved greater than 70% liver fat reduction (in each case, with p < 0.0001). DD01 achieved a mean reduction of liver fat content of 62.3% vs 8.3% for placebo at 12 weeks of treatment, and 48.5% of DD01 subjects achieved normalization of liver fat fraction (defined as liver fat fraction of 5% or less by MRI-PDFF). No placebo subject achieved normalization. Treatment related reductions in Non-invasive markers of MASH progression were used to evaluate subjects at baseline and after 12 weeks of treatment. DD01 treatment was associated with statistically significant improvements in liver stiffness (MRE), pro-C3 levels, and ELF score. Additional Endpoints Twelve-week weight loss data were encouraging. While placebo-treated subjects had no significant weight loss, 42.4% of DD01-treated subjects achieving a greater than 5% reduction in weight. Also encouraging were the results of HbA1c testing. While the study population was not selected to be diabetic, following 12 weeks of DD01 treatment, HbA1c reduction was statistically significant compared to placebo. Safety Results DD01 was well tolerated. Gastrointestinal (GI) side effects were most common, generally mild to moderate, but transient and manageable. To date, only 3 subjects have discontinued treatment due to GI-related adverse events. Implications Seulki Lee, Ph.D., President and Chief Executive Officer of D&D Pharmatech, stated, 'We have remarkably positive results for DD01 after only 12 weeks of treatment in MASH. The magnitude of improvements is equivalent to what has been achieved only after longer-term treatment with FGF and GLP-1 based drugs already validated with histology data in MASH.' 'Considering the combination of liver and metabolic benefits and the favorable tolerability profile, DD01 has the potential to provide patients and physicians with a MASH treatment that is easy to manage, encourages weight loss and is diabetes friendly.' Mazen Noureddin, MD, MHSc, Professor of Medicine at Houston Methodist Hospital; Co-Chairman of the Board, Summit & Pinnacle Clinical Research; Director, Houston Research Institutes, commented, 'The degree of liver fat reduction with DD01 is striking, with nearly three-quarters of patients achieving at least a 30% reduction and almost half reaching normalization within just 12 weeks. The observed improvement in liver stiffness by MRE, though early, adds further support to the biological activity of this dual GLP-1/glucagon approach, which is designed to act directly on the liver.' 'These consistent MRI-PDFF results provide strong confidence that DD01 has the potential to meet both key regulatory endpoints - MASH resolution and fibrosis improvement - as the program advances. Coupled with favorable metabolic effects and a very low treatment discontinuation rate, DD01 is emerging as a well-differentiated and promising therapy, both within its class and compared to other potent agents in development.' Additional data will be presented at upcoming medical meetings. About DD01 DD01 is a once-weekly dual GLP1/glucagon receptor agonist with a half-life of 7-8 days in obese/overweight patients with T2D and MASLD. Following a Phase 1 study that showed DD01 rapidly reduced liver steatosis, improved glucose tolerance, and encouraged weight loss in obese subjects with MASLD and type 2 diabetes, FDA granted DD01 Fast Track Designation for the treatment of MASH. Current Phase 2 results confirm and extend these findings revealing additional benefits in patients with MASH. The effect of DD01 is consistent with its dual-agonist pharmacology. Clinical results show the effects of DD01 are remarkably rapid. DD01 achieves robust results rapidly and with tolerability comparable to other validated MASH treatments. The GLP1:glucagon potency ratio for DD01 is 11:1. GLP-1R potency is likely an important driver in glucose management for diabetic patients and in weight loss. Importantly, with this ratio, DD01 is clearly also a potent glucagon receptor agonist. Substantial liver fat reduction was observed after only 4 weeks in obese subjects with MASLD (Phase 1). Liver fat reduction by DD01 is clearly not secondary to weight loss at these early timepoints, differentiating it mechanistically from the pure incretin approach. In terms of the balance between efficacy and tolerability, the pharmacokinetics of DD01 are also unique. Good tolerability at clinically active doses is likely aided by very slow absorption (tmax = 6 days) and a long half-life (7-8 days), features which make the onset and rise in DD01 exposure gradual. Peaks associated with poor tolerability and troughs associated with diminished efficacy are avoided. As a result, the need for a lengthy titration period is eliminated and therapeutic levels are reached rapidly. A key differentiator for DD01 is the balanced constellation of clinical benefits afforded by a unique pharmacologic and pharmacodynamic signature. Current data suggest DD01 has the necessary attributes to offer patients and physicians a treatment that is easy to use, supports both liver and metabolic health. About the DD01-DN-02 Trial With the support of staff at Summit Clinical Research, the study investigators, and the study participants, the DD01-DN-02 study is fully enrolled and currently ongoing at 12 centers in the U.S. Baseline characteristics were well balanced between both treatment groups with nearly identical mean liver fat fractions (overall mean of 20.7%) and similar body weight (overall mean 99.4 kg) at baseline. Treatment is ongoing and the study includes non-invasive and histologic assessments of MASH resolution and change in fibrosis at 48 weeks. More information about the study is available at under the identifier NCT06410924. About D&D Pharmatech D&D Pharmatech is a clinical-stage biopharmaceutical company focused on developing revolutionary medicines for patients with a number of metabolic, fibrotic, and neurodegenerative diseases. DD01 and TLY012 are in development for fibrotic liver disease (MASH and cirrhosis). TLY012 has completed IND-enabling studies and has been shown to slow and even reverse established fibrosis in models of liver cirrhosis, chronic pancreatitis, and systemic scleroderma. Two products are in development for neurodegenerative diseases. NLY02 is a small molecule BBB penetrating kinase inhibitor targeting glial activation. It is a potent inhibitor of neurodegeneration. NLY01 is also a potent inhibitor of glial activation. It acts through the incretin pathway to reduce neuronal loss and slow functional decline in models of Parkinson's, Alzheimer's, and multiple sclerosis. In a recently completed Phase 2 study conducted in >250 Parkinson's patients, 36-week of treatment with NLY01 resulted in a significant reduction in motor function decline (UPDRS III) in ~1/3 of trial subjects. NLY01 appeared to slow the progressive decline in motor function in newly diagnosed patients who were young (<60) and treatment naïve. D&D Pharmatech's ORALINK technology allows efficient oral uptake of therapeutic peptides. In partnership with Metsera, the company is developing orally active incretin-based peptide drugs for obesity.
Medscape
09-05-2025
- Health
- Medscape
Efruxifermin Shows Fibrosis Reduction in MASH Cirrhosis
AMSTERDAM — A once daily, 50 mg dose of efruxifermin reduced fibrosis at 96 weeks in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) compared with placebo, but it did not significantly reduce fibrosis at 36 weeks (primary endpoint), according to results from the phase 2b SYMMETRY trial. Efruxifermin is a long-acting, bivalent fibroblast growth factor 21 analogue. At 96 weeks of treatment, a statistically significant 29% of patients had at least one stage of fibrosis improvement without MASH worsening (secondary outcome) compared with 11% on placebo. Results also suggested improvements in MASH-related histologic findings, non-invasive markers of liver injury and fibrosis, as well as markers of glucose and lipid metabolism at 96 weeks. Now the 50 mg dose of efruxifermin is being investigated in phase 3 development. Mazen Noureddin, MD, MHSc Academic-clinician Mazen Noureddin, MD, MHSc, of the Sherrie and Alan Conover Center for Liver Disease and Transplantation at Houston Methodist Hospital, Texas, presented the findings here at the at the European Association for the Study of the Liver (EASL) Congress 2025. The work was published simultaneously in The New England Journal of Medicine . Noureddin said that, for the first time, they showed 'significant, unprecedented improvement in fibrosis' on the regimen. He added that the 'histologic improvement in fibrosis corroborated with non-invasive tests, presenting an overall picture of liver injury and function that suggests liver health is maintained or slightly improved by efruxifermin compared to placebo.' Despite being a major cause of liver failure and transplantation, there are currently no approved therapies that reverse fibrosis in MASH-related cirrhosis. Efruxifermin has shown antifibrotic effects in earlier studies of patients with less advanced disease (F2-F3 fibrosis). Now, this phase 2b, randomized, placebo-controlled, double-blind trial, shows efficacy and safety with efruxifermin in patients with MASH who had biopsy-confirmed compensated cirrhosis at stage 4 fibrosis. The Trial SYMMETRY was conducted across 45 sites in the US, Mexico, and Puerto Rico. It enrolled 181 adults with biopsy-confirmed compensated cirrhosis due to MASH (Child-Pugh A), 80% of whom had diabetes and obesity. Patients were at high risk for hepatic decompensation. Participants were 18-75 years of age, had liver histologic features consistent with MASH, and had compensated cirrhosis (stage 4 fibrosis with a Child-Pugh score of 5 or 6). They also had type 2 diabetes or two components of metabolic syndrome comprising obesity, dyslipidemia, elevated blood pressure, and elevated fasting glucose level. Approximately 80% of the patients had biopsy-confirmed MASH. Patients received weekly subcutaneous efruxifermin (28 mg or 50 mg) or placebo in a 1:1:1 ratio. Liver biopsies were obtained at weeks 36 and 96 and were included in the intention-to-treat and safety analyses. Overall, liver biopsy data were available for 154 patients at week 36 and for 134 patients at week 96. The primary endpoint comprised a reduction of at least one stage of fibrosis without worsening of MASH at week 36, while the same measure comprised the secondary outcome at week 96. At 36 weeks, in the intent-to-treat analysis, a reduction in fibrosis without worsening of MASH was seen in 8/61 patients (13%) in the placebo group, 10/57 patients (18%) in the 28 mg efruxifermin group (95% CI, -11 to 17; P = .62), and 12/63 patients (19%) in the 50 mg efruxifermin group (95% CI, -10 to 18; P = .52). Referring to the 36-week completer analysis, Noureddin reported, 'We see here, 24% in the 50 mg group compared with 14% in those on placebo [and 22% on the 28-mg dose]. When they continue treatment up to 96 weeks, we saw up to 39% improvement [50-mg dose] in fibrosis by one stage without worsening of MASH compared to 15% placebo [and 29% with 28 mg]. This is a difference of 24% [between placebo and 50 mg] that was statistically significant [ P < .01],' he reported. In the intent-to-treat analysis, at week 96, a reduction in fibrosis without worsening of MASH occurred in 7/61 patients (11%) in the placebo group, in 12/57 patients (21%) in the 28 mg efruxifermin group (95% CI, -4 to 24), and in 18/63 patients (29%) in the 50 mg efruxifermin group (95% CI, 2-30). 'It was up to 29% in the 50 mg compared with 11%, and that's an 18% statistically significant difference [ P < .05].' The proportion of week 36 responders who sustained response to week 96 were 50% (n = 4), 67% (n = 6), and 75% (n = 9), in the placebo, 28 mg, and 50 mg groups, respectively. Expanded response (non-response at week 36 but response at week 96) was 8% (n = 3), 19% (n = 6), and 26% (n = 9) respectively. 'This emphasizes the role of ongoing treatment in cirrhotic patients,' said Noureddin. He also added that they saw 'consistent responses across multiple baseline subgroups for the primary histological endpoint and at week 96 with the 50 mg.' Nearly all participants (99% on efruxifermin and 97% on placebo) reported adverse events. Any serious adverse events were reported in 26%, 24%, and 18% in the 28 mg, 50 mg, and placebo groups, respectively. Gastrointestinal side effects were most common: diarrhea (42%, 54%, and 30% on 28 mg, 50 mg, and placebo, respectively), nausea (30%, 46%, 30%, respectively), and increased appetite (16%, 40%, 7%, respectively) and mostly of mild-to-moderate nature. Administration-site reactions (erythema) were also more common with efruxifermin (13%, 16%, and 6%, respectively). After week 36 and prior to week 96, discontinuations due to adverse events were 0%, 2%, and 3% in the placebo, 28 mg, and 50 mg, respectively. 'After week 36, there were very few discontinuations due to side effects,' reported Noureddin. Poor bone health is a common complication of cirrhosis, and across all treatment groups, 43% of participants had osteopenia at baseline, but only 4% were treated with bisphosphonates. Placebo-adjusted, significant relative reductions in bone mineral density (-5%) for spine and hip were observed for both treatment groups at week 96 or about 2%-3% per year. The number of participants experiencing fractures was equal across all treatment groups, added Noureddin. Commenting on the study, delegate and chairman of the Global NASH Council, Zobair M Younossi, MD, professor and chairman of the department of medicine at Inova Fairfax Medical Campus, Fairfax County, Virgina, told Medscape Medical News , 'The key to this whole area is that there are treatments that have been developed for non-cirrhotic MASH, F2 and F3, but there is currently nothing that is positive for people with cirrhosis and MASH. This study shows there is improvement in all categories even in those with diabetes and even when they are controlled for some alcohol consumption.' He added, 'I think that the best aspect of this is that it gives us a potential treatment for those patients who are at highest risk for bad outcomes in MASLD, which are those with cirrhosis.' The study was supported by Akero Therapeutics. Noureddin declared grants, consultant roles, and stock options from many pharmaceutical companies, including Akero. Younossi reported no relevant financial relationships.
Yahoo
09-05-2025
- Business
- Yahoo
Akero Therapeutics Presents Week 96 Results from Phase 2b SYMMETRY Clinical Trial of Efruxifermin in Patients with Compensated Cirrhosis Caused by MASH Showing Fibrosis Improvement without Worsening of MASH at the EASL Congress 2025
SOUTH SAN FRANCISCO, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, presented results from the Phase 2b SYMMETRY trial demonstrating the potential of efruxifermin (EFX) to improve fibrosis in compensated cirrhosis (F4) caused by metabolic dysfunction-associated steatohepatitis (MASH), in a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, in Amsterdam, the Netherlands. 'Compensated cirrhosis due to MASH remains a high unmet medical need, leaving patients with a poor prognosis and currently no effective treatment options beyond liver transplant,' said Kitty Yale, chief development officer of Akero. 'These data presented at the EASL Congress 2025 differentiate EFX from other approved or investigational MASH treatments as the first to demonstrate fibrosis reversal in patients with MASH caused by cirrhosis. We look forward to continuing evaluation of EFX across all stages of MASH in our Phase 3 SYNCHRONY program.' 'Patients with cirrhosis caused by MASH could face a 50 percent chance of dying within five years without a liver transplant,' said Mazen Noureddin, M.D., Professor of Medicine and Transplant Hepatologist at Houston Methodist Hospital, and principal investigator for the SYMMETRY study. 'EFX's powerful anti-fibrotic activity, as observed in the Phase 2b SYMMETRY trial and currently being evaluated in Phase 3, has the potential to be the most substantial medical breakthrough in my career as a treating physician.' Week 96 data presented from SYMMETRY, a Phase 2b trial evaluating the efficacy and safety of Akero's lead product candidate, EFX, in patients with biopsy-confirmed compensated cirrhosis (F4) due to MASH, showed fibrosis reduction without MASH worsening by both completer and intent-to-treat (ITT) analyses after 96 weeks. In the pre-specified analysis of patients with baseline and week 96 biopsies (N=134), 39% of patients treated with EFX 50mg had fibrosis improvement compared to 15% of placebo-treated patients (p=0.009). In the ITT population (N=181), with missing week 96 biopsies treated as non-responders, 29% of patients in the EFX 50mg group experienced this improvement, compared to 11% for placebo (p=0.031). The primary endpoint of the SYMMETRY study was ≥1 stage fibrosis improvement with no worsening of MASH at Week 36. A numerical improvement was observed in the EFX groups vs. placebo at Week 36 but the differences were not statistically significant. Summary of Week 96 Fibrosis Improvement without MASH Worsening Secondary Endpoint Primary Analysis (N=134)1 ITT Analysis (N=181)2 Histology Endpoint3 (Proportion of Patients) Placebo(N=47) EFX 28mg(N=41) EFX 50mg(N=46) Placebo(N=61) EFX 28mg(N=57) EFX 50mg(N=63) ≥1 stage fibrosis improvement without worsening MASH (%) 15 29 39 ** 11 21 29 * 1 All patients with baseline and week 96 biopsies2 The 47 randomized and dosed patients who had missing biopsies at week 96 are treated as non-responders in the ITT analysis (without imputation).3 Biopsies scored independently by two pathologists; third available to adjudicate (which was not required)* p<0.05, ** p<0.01, versus placebo (Cochran-Mantel-Haenszel test). Comparison of the proportion of patients with a fibrosis reduction at Week 36 and Week 96 in the pre-specified analysis of patients with baseline and week 96 biopsies, showed more than a doubling of placebo-adjusted treatment effect for the EFX 50mg group, from 10% to 24%. This increase in effect size shows the importance of longer treatment with EFX for patients with compensated cirrhosis (F4) as compared to responses observed in trials of EFX in patients with earlier stage fibrosis (F2 or F3). The larger treatment effect observed after 96 weeks is corroborated by changes in noninvasive measures of liver fibrosis and injury. For example, two key non-invasive measures of the extent of fibrosis development in the whole liver, ELF test score and liver stiffness by Fibroscan, showed continuing improvement over 96 weeks for the 50mg EFX group. Newly presented analyses showed EFX's potential to improve fibrosis among patients with compensated cirrhosis across key subgroups. Patients responded to EFX 50mg after 96 weeks regardless of type 2 diabetes status or treatment with GLP-1 medications or statins at baseline. The safety and tolerability profile of EFX was consistent with previous trials. The most frequent adverse events with EFX were gastrointestinal (diarrhea, nausea, increased appetite) and most were mild to moderate and transient. All serious adverse events were deemed to be unrelated to study drug. Details for the presentation are as follows: Title: Efruxifermin improves fibrosis in participants with compensated cirrhosis due to MASH: results of a 96-week, randomized, double-blind, placebo-controlled, phase 2b trial (SYMMETRY)Speaker: Mazen Noureddin, M.D., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research InstituteDate/Time: Friday, May 9, 2025, from 12:15 pm – 12:30 pm CET Abstract Identifier: GS-012Oral Session: General Session 2 About Cirrhosis Due to MASH Cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis) is a life-threatening disease with high risk of liver failure, cancer, and death. By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, which is the fastest growing cause of liver transplants and liver cancer in the United States and Europe. About the SYMMETRY Study SYMMETRY was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH. The study randomized 182 patients, and 181 received once-weekly subcutaneous EFX 28mg or 50mg, or placebo for 96 weeks. The primary efficacy endpoint was the proportion of patients with ≥1 stage fibrosis improvement without worsening of MASH at Week 36. Secondary efficacy measures at Week 96 included ≥1 stage fibrosis improvement without worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, serum markers of glucose and lipid metabolism, as well as safety and tolerability measures. About EFXEfruxifermin (EFX), Akero's lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date. About Akero Therapeutics Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (metabolic dysfunction-associated steatotic liver disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at and follow us on LinkedIn and X for more information. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero's business plans and objectives; the potential therapeutic effects and anti-fibrotic activity of EFX, as well as the dosing, safety and tolerability of EFX, the future potential and long-term benefits of EFX following the preliminary topline week 96 results of Akero's Phase 2b SYMMETRY study and the ongoing SYNCHRONY Phase 3 program. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero's ability to execute on its strategy; positive results from any of its clinical studies may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors'' in Akero's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact:Christina TartagliaPrecision AQ212.362.1200IR@ Media Contact:Peg RusconiDeerfield in to access your portfolio
Yahoo
30-04-2025
- Health
- Yahoo
Akero Therapeutics Announces Upcoming Poster and Oral Presentations at the EASL Congress 2025
SOUTH SAN FRANCISCO, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced two oral presentations and an upcoming poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, 2025, in Amsterdam, the Netherlands. Details for the presentations are as follows: Oral presentation 1 Title: Efruxifermin improves fibrosis in participants with compensated cirrhosis due to MASH: results of a 96-week, randomized, double-blind, placebo-controlled, phase 2b trial (SYMMETRY)Speaker: Mazen Noureddin, M.D., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research InstituteDate/Time: Friday, May 9, 2025, from 12:15 PM – 12:30 PM CETPresentation ID: GS-012Oral Session: General Session 2 Oral presentation 2 Title: Alignment of response assessed by non-invasive fibrosis biomarkers and HistoIndex AI-based qFibrosis histology in metabolic dysfunction associated steatohepatitis (MASH) clinical trials: a new roadmap for robust drug efficacy assessment demonstrated in the HARMONY trialSpeaker: Prof. Quentin M. Anstee, Ph.D., FRCP, Ruth & Lionel Jacobson Chair of Personalised Medicine, Dean of Research & Innovation in the Faculty of Medical Sciences, Newcastle University, UKDate/Time: Saturday, May 10, 2025, from 10:30 – 10:45 CETPresentation ID: OS-096Oral Session: MASLD: Clinical and therapeutical aspects II Poster presentation Title: qFibrosis enables earlier detection of fibrosis response in Efruxifermin-treated patients with F2-F3 MASH in 96-week HARMONY studyPresenter: Jörn M. Schattenberg, M.D., Professor of Medicine, Director of the Department of Medicine, Saarland University Medical Center, University of SaarlandDate/Time: Saturday, May 10, 2025, from 8:30 – 16:00 CETPresentation ID: TOP-458Session: Poster - MASLD: Therapy About Akero Therapeutics Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (Metabolic Dysfunction Associated Steatotic Liver Disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at and follow us on LinkedIn and X for more information. Investor Contact:Christina TartagliaPrecision Media Contact:Peg RusconiDeerfield in to access your portfolio
